May 2007

Washington, DC (Mar. 26)—The biggest issue in biopharmaceuticals continues to be the ongoing debate over regulation and oversight of follow-on biologics. Regulatory agency representatives, academia, and several professional industry organizations sounded off last month, voicing strong opinions and warnings of potential backlashes to healthcare, the economy, and scientific innovation.

The congressional Committee on Oversight and Government Reform (
http://www.oversight.house.gov/), chaired by Rep. Henry Waxman (D-CA) touched off the debate when it held a hearing to evaluate the cost of biotech drugs as well as strategies for establishing a process for the US Food and Drug Administration's approval of generic versions of these drugs. Janet Woodcock, MD, deputy commissioner for operations and chief medical officer at FDA was among those making a statement at the hearing entitled "Safe and Affordable Biotech Drugs—The Need for a Generic Pathway."

Woodcock attributed part of the increasing interest in follow-on versions of approved protein products to "advances in manufacturing technology, process control, and characterization" of these products. She acknowledged that the nature of protein products makes comparisons of one protein to another and establishing safety and efficacy "more scientifically challenging" than for small-molecule drugs. Nonetheless, Woodcock also stated that the agency has "considerable experience with reviewing some protein products, including cases where the agency has considered the extent to which existing conclusions about safety and effectiveness of a protein product could be applicable to another protein product based on data and information showing the similarity of the products."

The Biotechnology Industry Organization (BIO,
http://www.bio.org/) continues to voice strong opposition to the "Access to Life-Saving Medicine Act" (H.R. 1038), stating that the bill is "deeply flawed" because it "raises numerous patient safety concerns...It would eviscerate incentives to develop life-saving new medicines...[and] lacks data exclusivity for innovative biologics." In its letter to the committee, BIO also states that the potential savings in healthcare costs resulting from the establishment of a pathway for regulatory approval of follow-on biologics is "substantially overestimated."

Emphasizing a "vast difference" between generic pharmaceuticals and follow-on biologics, Jim Greenwood, BIO president and CEO, stated that "high manufacturing costs, the need for additional safety and efficacy in trials to test these products, and augmented efforts directed at doctors to encourage the use of similar, but not identical, drugs are expected to add to the prices associated with the follow-on product."

Company Notes

Caroline Loew, senior vice-president of the Pharmaceutical Research and Manufacturers of America (PhRMA,
http://www.phrma.org/) expressed reservations regarding follow-on biologics. Although she maintained that PhRMA would support the establishment of a regulatory pathway for follow-on biologics, the organization worries that the current legislative proposals could put patient safety at risk. PhRMA cites the "significant differences between biologic products from different manufacturers" and the fact that innovator biologics are not identical to follow-on biologics as factors that could affect patients. In addition, PhRMA is concerned that existing legislation allows for a follow-on biologic to be replaced with a similar product, even though the similar product could have a different makeup, at pharmacies, hospitals, and physicians' offices.